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Evidence from preliminary studies suggests that people with PTSD have heightened fear responses and that cortisol suppression reduces this heightened fear. Research has shown the drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians with PTSD. This current research proposal represents a blinded, randomized, placebo-controlled efficacy study with the goal of determining whether a drug that suppresses the stress hormone cortisol will increase the efficacy of exposure therapy. Specifically, it is proposed that a dose of DEX, given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions, will significantly enhance the rate of response and possibly the efficacy of treatment. Participants will be treated until they have experienced at least a 70% reduction in PTSD symptoms from baseline or up to 12 sessions or until they and their therapist agree treatment should be terminated, a minimum of 6 sessions to a maximum of 12 sessions. Comprehensive multi-modal outcomes will be assessed by independent assessors blind to subject condition on interviews, self-report measures, and psychophysiological measures. Participants will be assessed pre- and post-treatment and at a follow-up of 3, 6 and 12 months to assess long term effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone + VRE | Active Comparator | 0.5 mg DEX + virtual reality exposure therapy |
|
| Placebo + VRE | Placebo Comparator | Placebo + virtual reality exposure therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality exposure therapy | Behavioral | Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in The Clinician Administered PTSD Scale (CAPS)Scores | The Clinician Administered PTSD Scale (CAPS) provides a diagnostic measure of PTSD and a continuous measure of the severity, frequency, and intensity of the three symptom clusters (intrusion, avoidance, and arousal) and overall PTSD. The assessor combines information about frequency and intensity of an item into a single severity rating. Severity Rating: 0. Absent; 1. Mild / subthreshold;2. Moderate / threshold; 3. Severe / markedly elevated; 4.Extreme / incapacitating. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Scores may range from 0-80, with a higher score indicating more reported symptoms of PTSD. | Baseline and immediate post treatment (up to 12 weeks from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in The PTSD Symptom Scale Scores | The PTSD Symptom Scale (PSS) is a 17-item interview used to aid in the detection and diagnosis of PTSD. The structure and content of the PSS mirror the DSM-IV criteria for PTSD. For each item, the interviewer assigns a rating to reflect a combination of frequency and severity (from O = "not at all" to 3 = "5 or more times per week/very much"). Scores range from 0-51, with higher scores indicating more reported symptoms of PTSD. A score of 13 or higher indicates the likelihood of PTSD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Rothbaum, Ph.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30306 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone + VRE | 0.5 mg DEX + virtual reality exposure therapy Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently. 0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions. |
| FG001 | Placebo + VRE | Placebo + virtual reality exposure therapy Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone + VRE | 0.5 mg DEX + virtual reality exposure therapy Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently. 0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in The Clinician Administered PTSD Scale (CAPS)Scores | The Clinician Administered PTSD Scale (CAPS) provides a diagnostic measure of PTSD and a continuous measure of the severity, frequency, and intensity of the three symptom clusters (intrusion, avoidance, and arousal) and overall PTSD. The assessor combines information about frequency and intensity of an item into a single severity rating. Severity Rating: 0. Absent; 1. Mild / subthreshold;2. Moderate / threshold; 3. Severe / markedly elevated; 4.Extreme / incapacitating. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Scores may range from 0-80, with a higher score indicating more reported symptoms of PTSD. | Posted | Mean | Standard Deviation | units on a scale | Baseline and immediate post treatment (up to 12 weeks from baseline) |
|
12 months of follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone + VRE | 0.5 mg DEX + virtual reality exposure therapy Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently. 0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Rothbaum | Emory University | 404-712-8866 | brothba@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2015 | Apr 17, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D063367 | Virtual Reality Exposure Therapy |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| 0.5 mg DEX | Drug | A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions. |
|
|
| Baseline and immediate post treatment (up to 12 weeks from baseline) |
| BG001 | Placebo + VRE | Placebo + virtual reality exposure therapy Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
0.5 mg DEX + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions.
| OG001 | Placebo + VRE | Placebo + virtual reality exposure therapy Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently. |
|
|
| Secondary | Change in The PTSD Symptom Scale Scores | The PTSD Symptom Scale (PSS) is a 17-item interview used to aid in the detection and diagnosis of PTSD. The structure and content of the PSS mirror the DSM-IV criteria for PTSD. For each item, the interviewer assigns a rating to reflect a combination of frequency and severity (from O = "not at all" to 3 = "5 or more times per week/very much"). Scores range from 0-51, with higher scores indicating more reported symptoms of PTSD. A score of 13 or higher indicates the likelihood of PTSD. | Posted | Mean | Standard Deviation | units on a scale | Baseline and immediate post treatment (up to 12 weeks from baseline) |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Placebo + VRE | Placebo + virtual reality exposure therapy Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |